17 results · 24ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

PurePrep Path DX Kit (96 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

PurePrep Path DX Kit (480 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit (MDX) (10 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit (MDX) (250 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit (MDX) (50 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (480 rxn) Plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (480 rxn) Plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (96 rxn) stripes

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Blood DNA Mini Kit – IPC16 (MDX) (16 rxn) Plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (96 rxn) Sprips

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus DNA/RNA Kit – IPC16 (MDX) (16 rxn) Plates

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (96 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

deltaPREP Virus PLUS Kit - Multi-Device 96 (MDX) (480 rxn)

Device
EU IVDR · Eu Ivd Class A ·IST Innuscreen GmbH·On the market

GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system

FDA Enforcement
Class II ·Ongoing·GE Healthcare GmbH·December 24, 2025